Metal implants cannot be placed in deficient bone sites without the use of guided bone grafting regeneration procedures. Such procedures are clinically necessary in osseous defects for implant installation in orthopedics and dentistry. Grafting materials that may be used for guided bone regeneration include autograft bone, allograft bone and synthetic bioactive resorbable crystals, having physicochemical properties and biologic resorption rates to human bone. However, use of ceramic hydroxyapatite granules, bovine ceramic granules, tricalcium phosphate ceramic granules, glass and/or plastic granules results in negative systemic consequences further compromising the patient's immune system due to lack of resorption and physicochemical dissimilarities to human bone. Such materials are all considered non-resorbing filler materials which do not turn into bone, or resorb, due to their high mechanical properties and chemical dissimilarities to human bone.
Various titanium implant modalities (orthopedic or dental) have been developed in recent years with a variety of modified chemical surfaces, claiming biological protein attachment, cell attachment, and cell proliferation on their surfaces. These include ceramic hydroxyapatite coating, or calcium phosphate ceramic coating and titanium surface coating. Acid processing with fluoride surface treatment of implants and fluoride surface painting procedures have heretofore not provided any beneficial results, noting bone breakdown.
It has been reported that osteoblast proliferation and differentiation, as detected by alkaline phosphatase biochemical osteoblast marker activity, may be facilitated through free fluoride dried on the surfaces of implantable materials and devices. Free fluoride studies have been carried out for many years and have found that free fluoride may activate rapid and uncontrolled dissolution of bone, which may improve the rate of sporadic mineral apposition; however, the concentrations of free fluoride used in these studies vary considerably depending on the research equipment and testing methods used to evaluate the results. This wide range of free fluoride has not been narrowed down to an optimal free fluoride concentration by a controlled delivery mechanism with beneficial results, and without the consequences of bone necrosis due to the free fluoride's acidic poisonous nature and rapid immediate bone resorption.
There have been numerous studies of free fluoride clinical applications on the surface of human enamel carried out from the perspective of preventing caries. The concept of using sodium fluoride (NaF) to prevent caries emerged on the notion that free fluoride would either be “firmly bound” or “loosely attached” to enamel surface. This is based on early reports from in vitro studies on necrotic human tooth enamel surfaces, and clinical studies on human tooth enamel. This concept did not materialize, but instead resulted in deleterious outcomes and host bone necrosis. Hypothetically, these are alkali-“insoluble” and alkali-soluble fluorides, respectively, on various surfaces, with regard to solubility, using potassium hydroxide and with sodium-fluoride applications. Consecutive studies focused on the dissolution and mobility of free fluoride after topical applications in human and bovine tooth enamel surfaces. However, results failed to show controlled distribution of fluoride and any binding capacity to enamel surfaces. Therefore, no benefit was achieved by using free fluoride due to its instantaneous release to the cellular environment.
In other reports, mouse stem cells and osteoblast-like ROS cells responded to similar, or slightly lower, ranges of free fluoride substitution and showed good proliferation. Studies on epithelial cells in vitro focused on the presence of minute quantities of free fluoride from 5 to 50 μm (0.095-0.95 ppm F) in the culture medium, which promoted cell proliferation of human gingival epithelial cells (HGEC) and human epidermal cells (HaCaT) after 48-hour exposure. A significant difference was reported for proliferation of both cell types. The presence of “minute quantities” of free fluoride led to the production of fibronectin and laminin-5, which play a major role in cell adhesion and proliferation.
In view of the foregoing, there exists a need for bone graft and method of use that addresses the deficiencies of the related art for quicker and safer bone formation.